Sage Therapeutics and Biogen announce FDA accepts filing of new drug application and grants priority review of zuranolone in the treatment of major depressive disorder and post-partum depression

Sage Therapeutics

6 February 2023 - Zuranolone is being evaluated as a potential 14 day, rapid acting, once daily, oral medication to treat major depressive disorder and post-partum depression.

The application has been granted priority review and the FDA has assigned a PDUFA action date of 5 August 2023.

Read Sage Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier